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510(k) K072309

Device
MICROLUX/BLU
Applicant
Addent, Inc.
510(k) number
K072309
Product code
EAZ
Decision
Substantially Equivalent (SESE)
Decision date
2007-11-19
Date received
2007-08-17
Regulation
872.4630
Classification name
Light, Operating, Dental
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
JOSHUA FRIEDMAN, DDS
Address
43 Miry Brook Rd. Danbury CT US 06810 06810

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EAZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K041614MICROLUX DLAddent, Inc.2005-04-04
K033033VIZILITE-BLUE ORAL EXAM KITTrylon Corp.2004-11-22
K003995SPECULITE/ORALLITETrylon Corp.2001-03-16
K926081DENTAL LIGHTMdt Corp., Inc.1994-01-26
K935390SIROLUX FANTASTICPelton & Crane Co.1993-12-10
K925629ACCESSORY TO IMPROVED DENTAL OPERATING LIGHTDen-Tal-Ez Mfg Co., Inc.1993-11-23
K923462DELIGHTPlanmeca USA, Inc.1992-12-21
K912142MICRONAIRE ISO-HOOD MAX 5UVMicronaire Corp.1991-10-30
K912997MINIFLEX AND PERSONAL UNITDabi-Atlante America Corp.1991-10-30
K902685DEFIANCE MODEL FUS 336Defiance Electronics, Inc.1990-09-17
K894059ISOLIGHTEurodent, Inc.1989-09-07
K893044A-DEC DENTAL LIGHTA-Dec, Inc.1989-07-14
K891216DENTAL EQUIPMENT PROTECTION DEVICESPro-Safe Professional Linens, Inc.1989-06-02
K884223DENTAL LAMP HANDLE COVERSteri-Shield Products, Inc.1989-03-17
K874374THE WOOG ORATESTWoog Intl.1988-01-19